Customized Plate and Screw Sterile Kits

Indications: The sterile kit configurations for use with the Bioplate® Fixation System may be used for surgical procedures in which metallic internal fixation is required to align and stabilize bony tissue, including, but not limited to, craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton. A number of surgical techniques may be used for craniofacial fixation and other materials used for the same purpose are also available. The selection of the type of fixation device, its composition, size and shape is made by the surgeon after evaluation of the anatomical and functional demands of the patient. The following are specific contraindications, adverse effects, and warnings that must be understood by the surgeon and explained to the patient. The general surgical risks that are not included should also be explained to the patient prior to surgery.

Contraindications:

1. Active infections.
2. Patients who are unwilling or unable to follow postoperative instructions due to accompanying conditions (mental or physical).
3. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made to rule out this possibility prior to implantation.
4. Inadequate quality or quantity of bone for secure anchoring of the implants.
5. Limitations in blood supply and/or previous infections that may slow healing and increase the possibility of infection and/or rejection of the implants.
6. Any degenerative disease process that would adversely affect proper placement of the implants.
7. Inadequate coverage of healthy tissue.
8. Procedures in which a no-sterile environment exists, i.e., approximating open cavities, such as sinuses.
9. Use in weight bearing and/or load bearing areas.
10. Pedicle screw fixation.

Possible Adverse Effects:

1. Decrease in density of bone and/or necrosis of bone due to stress shielding.
2. Vascular changes.
3. Allergic reaction or metal sensitivity to implant.
4. Nerve damage due to surgical trauma.
5. Breakage of implant due to nonunion or delayed union of bony tissue.
6. Bending or fracture of fixation devices.
7. Migration or loosening of fixation devices.
8. Pain, discomfort, and/or abnormal sensation due to presence of fixation devices.
9. Superficial and/or deep infection.
10. Growth restriction.
11. Passive transmigration of the fixation devices.
12. Tissue staining.

Warnings:

1. DO NOT USE devices that have been previously opened without resterilization. DO NOT USE if there is a loss of integrity of the sterile packaging of the devices. THE MATERIAL COVERING THE IMPLANTS IN THE PLASTIC DEVICE HOLDER IS INTENDED TO PREVENT THE IMPLANTS FROM BEING DISLODGED DURING THE ASEPTIC TRANSFER PROCESS AND DOES NOT PROVIDE A STERILE BARRIER. The titanium plate and screws that have not come into contact with a patient can be placed in the appropriate sterilization tray and resterilized using the recommended sterilization parameters included in this package insert. In general, surgical implants must never be reused, and explanted implants must never be reimplanted. Small defects and internal stress patterns may be present, even if the implant appears intact, and may cause failure and breakage of the implant.
2. Adequate patient instruction is a key factor in determining the success of the surgical procedure. Postoperative follow-up and care is very important. The patient must be made aware that a metallic implant is not as strong as normal bone and that excessive physical activity or load bearing may cause loosening, migration, bending, or fracture of the implants.
3. The success of any metallic fixation device is dependent upon careful handling and good surgical technique. Shaping and contouring of metallic implants should be avoided if possible. However, if contouring is required for proper application and the design of the implant allows for it, the surgeon should avoid using sharp bends, reverse bends, and bends at the site of screw holes. The surgeon should also avoid scratching or notching the surface of the implant with sharp instrumentation during contouring. Internal stress patterns can be produced that may cause eventual breakage of the implant. Excessive torque used to insert the screws into bony tissue may also cause screws to fracture during use. With any implantable device, there is a risk of introducing foreign materials and particulate matter, including glove talc, lint from draping materials, cleaning agents and other surface contaminants. All efforts should be made to limit handling of the fixation devices. In addition, if any fixation device comes into contact with body fluid, it should not be reused, due to possible transmission of blood borne pathogens.
4. Use of dissimilar metals in close contact with each other (i.e. screws used with a bone plate) can cause an increase in the corrosion process that may enhance metal fatigue and fracture of these implants. Titanium and titanium alloy plates and screws should be used together, without the addition of any other type of metal implants. Use of instruments not specifically designed for use with titanium fixation devices may cause device failure.
5. Metallic implants may loosen, corrode, migrate, cause pain, or fracture, even after a fracture site has healed. This is especially true in young, active patients. When deciding to remove the implant(s), the operating surgeon must consider the risks and benefits to the patient. If the implant is removed, the patient must receive appropriate postoperative management to avoid refracture of the bony tissue.
6. Proper selection of the implant size, configuration, and location will increase the potential for success of the fracture fixation. The surgeon must be thoroughly familiar with the implants, the method of application, the instrumentation, and the surgical procedure. Emergency screws are provided in the event that the pilot hole is of a diameter too large for adequate gripping of the standard screw. Metallic implants are intended to assist in the healing of bony tissue, not to replace normal tissues. These implants are not designed for use in weight bearing or load bearing applications. The patient must be made aware of the risks of using the devices, including possible adverse effects.
7. Staining of surrounding tissue has been reported with the use of similar titanium fixation devices, after these devices have come in contact with human tissue. Fragments and micro particles may become dislodged from the fixation device and may migrate from the implantation site. Once a fixation device is implanted, metallic particles may remain in the body after removal. Long-term effects of these particles are not currently known. It is possible that in the future adverse effects of these particles may become evident.
8. Special considerations are required in the use of this device for pediatric patients. Evidence suggests that growth restriction may occur with these implants. More importantly, intracranial translocation has been described with similar devices. Potential consequences may include intracerebral translocation with associated seizure activity and/or cerebral laceration with permanent disability or death. Use of this device in the pediatric population should be performed only by physicians qualified by specialized education and training. Removal of implants should be strongly considered after adequate healing has occurred.
9. The drill bits are designed to be discarded after each patient use. Always review the instruction manual and warning notices of the instrument manufacturer, as improper use may cause serious injury. Eye protection should be worn at all times.
10. Responsibility for completion of adequate training, proper patient selection, choice and placement of implants, and the decision to leave or remove implants postoperatively rests with the physician.
11. It is recommended that the LP (Low Profile) cross drive screws are only engaged once onto the driver blade. Thus LP cross drive screws that are engaged onto a blade and not used may be removed and discarded.
12. Re-use of the device would introduce a risk of cross-infection to the patient, similar to re-use of any device.